Baxter International and Halozyme Therapeutics announced that the United States Food and Drug Administration (FDA) approved Baxter’s subcutaneous treatment for adult patients with primary immunodeficiency (PI), HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase].
HYQVIA is the first subcutaneous immune globulin (IG) treatment approved for PI patients with a dosing regimen requiring only one infusion up to once per month (every three to four weeks) and one injection site per infusion to deliver a full therapeutic dose of IG. The majority of PI patients today receive intravenous infusions in a doctor’s office or infusion center, and current subcutaneous IG treatments require weekly or bi-weekly treatment with multiple infusion sites per treatment.
”Patients with PI value treatments that offer efficacy, safety and tolerability. Since each person with PI responds differently to treatment, having options that meet these individual needs is critically important,” commented Marcia Boyle, President and Founder of the Immune Deficiency Foundation. ”We commend Baxter for its significant commitment and investment in the development of HYQVIA.”
”The availability of HYQVIA has a significant impact on the treatment of PI, allowing for effective delivery of a full therapeutic dose of IG less frequently than other subcutaneous treatments (up to once a month), while maintaining the efficacy, safety and tolerability profile that is most important for patients,” said Ludwig Hantson, Ph.D., President of Baxter BioScience. ”This approval highlights the support of the patient community for new treatment options.”
”Today’s FDA approval of HYQVIA is a significant milestone for Halozyme as it represents the first U.S. approved Biologics License Application which utilizes our rHuPH20 platform,” commented Dr. Helen Torley, President and Chief Executive Officer of Halozyme. ”I would like to thank the talented teams at both Halozyme and Baxter for their dedication to bring a new treatment alternative to PI patients managing a life-long disease.”
Baxter expects to launch HYQVIA in the U.S. in the coming weeks. HYQVIA was approved in Europe in 2013 for adults (≥18 years) with primary immunodeficiency syndromes and myeloma or chronic lymphocytic leukemia (CLL) with severe secondary hypogammaglobulinemia and recurrent infections. It is currently being prescribed in several European countries, including Germany, Netherlands, Sweden, Norway, Denmark, Ireland and Italy.